Inspection Team Lead, 3rd Shift

Inspection Team Lead, 3rd Shift Summary The primary responsibility of the Inspection Team Lead is to perform continuous monitoring of the inspection process and provide in-process daily review of executed batch record and form entries. In addition, they will perform inspection to identify and remove critical, major, and minor defects from finished product according to standard procedures. They will be responsible for meeting/exceeding production standards, maintaining product quality, and minimizing/preventing equipment downtime. The ideal candidate will ensure compliance with quality systems, policies, procedures, and cGMP practices and collaborate effectively with internal partners, clients, and vendors. The hours for the Inspection Team Lead, 3rd Shift are 10:00pm - 6:30am. Essential Job Functions: Assist Inspection Supervisor, supporting a team of 6 to 10 associates daily, to inspect syringes and vialsFollow production and manufacturing proceduresInspect filled product container for cosmetic, particle and integrity defectsPerform reconciliation of finished inspected product and defectsAssist in writing and implementing area’s process documentsOperate equipment in compliance with SOPsAssure compliance with cGMP requirements (current good manufacturing practices)Complete and review associated production records, logbooks and formsAssist in performing and documenting Knapp and probability of detection studiesTrain new inspectors in accordance with inspector certification proceduresMentor new inspection associatesTrain new employees to perform manufacturing inventory transactions in the ERP systemAssist other manufacturing functions (Formulation, Fill, Materials) as requiredPerform duties gowned in Grade C, D, and controlled non-classified cleanroomsPerform cleaning and sanitization activities as neededCollaborate and communicate with cross functional teamsWork flexible hours to ensure production facility coverage Special Job Requirements: Aware of industry guidance and requirements applicable to visual inspection, including USP and and FDA Draft Guidance: Inspection of Injectable Products for Visible Particulates (2021). Minimum Education and Experience: High School diploma required, minimum 2 years of GMP pharmaceutical experience in drug product inspection and/or packagingMust pass health and visual check and eye inspections annually for visual acuity and color blindness Additional Preferences: Previous manufacturing leadership experienceGood math and documentation skillsAbility to perform repetitive tasksAbility to learn and adapt to innovative ideasGood observation skillsInitiative-taking and CollaborativeEffective organization skills and diligentAbility to work with minimal supervision Additional info about INCOG BioPharma Services: At INCOG BioPharma we are building a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. We are in the process of constructing the GMP facility and organization from the ground-up, which gives us the opportunity to leverage the knowledge we’ve gained over our careers to “do it right” in all respects. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.